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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K001340
Device Name STACKABLE CAGE SYSTEM
Applicant
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact KAREN JURCZAK
Correspondent
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact KAREN JURCZAK
Regulation Number888.3060
Classification Product Code
MQP  
Date Received04/27/2000
Decision Date 07/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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